MAUDE Adverse Event Report: UMANO MEDICAL INC.; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	FM1000
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to umano medical representative that the bed is not sending signal to the hospital's nurse call system.There was no patient involvement.
Additional Manufacturer Narrative
Umano medical initially received a complaint regarding a malfunction in the bed exit system, specifically that the signal was not reaching the nurse call station.During a remote troubleshooting session with the client, the issue was identified as a failure of the electronic main board.A replacement part was promptly shipped to the client on 2024-08-09 to facilitate the repair.A preliminary medical device report (mdr) was proactively initiated, although confirmation of the completed repair had not been received at that time.Despite multiple follow-up attempts via email and telephone, the client did not confirm whether the repair had been carried out.The most recent follow-up, conducted on 2025-06-06, was also unsuccessful.However, given that 10 months have passed since the replacement part was shipped, and considering that the manufacturer made five follow-up attempts using various communication methods, it is reasonable to conclude that the repair was completed and that the device is now functioning as intended.Based on the available information, umano medical confirms that the root cause of the issue was a failure of the electronic main board component.

• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): UMANO MEDICAL INC.; 230 boulevard nilus-leclerc; l'islet, qc G0R 2 C0; CA G0R 2C0
• Manufacturer (Section G): UMANO MEDICAL INC; 230 boulevard nilus-leclerc; l'islet, qc G0R 2 C0; CA G0R 2C0
• Manufacturer Contact: saoussen gammoudi ; 230 boulevard nilus-leclerc; l'islet, qc G0R 2-C0 ; CA G0R 2C0
• MDR Report Key: 20160448
• Report Number: 3009591865-2024-00007
• Device Sequence Number: 17962613
• Product Code: FNL
• UDI-Device Identifier: 00670482000487
• UDI-Public: 010067048200048711211018
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FM1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown